Effects of Recruitment Maneuvers in Early Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) Patients

This study has been completed.
Sponsor:
Collaborator:
Chi Mei Medical Hospital
Information provided by (Responsible Party):
LUN WEI LIU, Chi Mei Medical Hospital
ClinicalTrials.gov Identifier:
NCT01114009
First received: April 26, 2010
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to evaluate the effect of lung recruitment maneuver in patients with early ALI/ARDS


Condition Intervention
Acute Respiratory Distress Syndrome
Lung Injury, Acute
Procedure: Lung recruitment maneuver
Procedure: Lung protective strategy group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of Recruitment Maneuvers in Early ALI and ARDS Patients

Resource links provided by NLM:


Further study details as provided by Chi Mei Medical Hospital:

Primary Outcome Measures:
  • 28-day hospital mortality [ Time Frame: Two year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ventilator-free days [ Time Frame: Two year ] [ Designated as safety issue: No ]
  • Ventilator weaning rate [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • Cost-effectiveness analysis [ Time Frame: Two years ] [ Designated as safety issue: No ]
  • ICU-free days [ Time Frame: Two years ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: March 2009
Study Completion Date: July 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lung recruitment maneuver
The maneuver briefly increases the alveolar pressure to open recruitable lung (50 cmH2O), sustained with adequate positive end-expiratory pressure(PEEP) after lung recruitment, to avoid derecruitment.
Procedure: Lung recruitment maneuver
Lung recruitment maneuver conducted with a PEEP 35 cmH2O and peak inspiration pressure up to 50 cmH2O maintain 2 mins, then find the closing pressure (if possible), after that, PEEP is set higher 2 cmH2O above closing pressure
Procedure: Lung protective strategy group
Lung protective strategy group received Lung protective strategy without recruitment maneuver
Other Name: Lung protective strategy group
Active Comparator: Lung protective strategy
Lung protective strategy group received lung protective strategy without recruitment maneuver
Procedure: Lung protective strategy group
Lung protective strategy group received Lung protective strategy without recruitment maneuver
Other Name: Lung protective strategy group

Detailed Description:

The acute respiratory distress syndrome (ARDS) was first described in the medical literature in 1967. Patients with ARDS mostly require mechanical ventilatory support due to hypoxic respiratory failure. Mechanical ventilation can induce lung injury (ventilator-induced lung injury, VILI) by causing overdistention and repetitive opening and closing of unstable lung units. Data from a number of randomized controlled trials indicate that a lung protective ventilatory strategy with small tidal volume and low plateau pressure reduces mortality in acute lung injury (ALI) and acute respiratory distress syndrome. Lung recruitment maneuvers are being used in the management of ALI and ARDS, but recruitment maneuvers are still controversial. Lung recruitment maneuver is aimed to open the collapsed lung and keep the lung open. The maneuver briefly increases the alveolar pressure to open recruitable lung, sustained with adequate positive end-expiratory pressure(PEEP) after lung recruitment, to avoid derecruitment. We want to enroll 120 patients with early ALI/ARDS in this randomized controlled study. The study group use recruitment maneuver and lung protective ventilatory strategy, and the control group use lung protective ventilatory strategy only. Concerning about both safety and efficacy, we design a modified recruitment maneuver protocol which has never been published in previous medical literature. The primary outcome is ventilator-free days and ICU-free days, and secondary outcomes include ventilator weaning rate, and 28-day mortality and cost effectiveness analysis. Since no randomized controlled trials clearly establish benefit from recruitment maneuvers, we hope this study would be able to provide some evidence on whether lung recruitment should be used in the routine management of ALI/ARDS.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • met criteria of ALI/ARDS
  • PaO2/FiO2 less than or equal 250 mmHg after standard ventilator setting (FiO2 more than or equal 0.5 and PEEP more than or equal 10 cmH2O)at least 30 mins

Exclusion Criteria:

  • age less than 18 years
  • duration of mechanical ventilator more than 72 hours
  • Pneumothorax or subcutaneous emphysema or bullous lung disease
  • severe chronic respiratory disease
  • intracranial hypertension or received craniotomy surgery
  • longterm dependent ventilator
  • Neuromuscular disease
  • premorbid conditions with an expected 6 month mortality risk exceeding 50%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114009

Locations
Taiwan
Chi Mei Medical Center,Liou Ying
Tainan, Taiwan
Sponsors and Collaborators
LUN WEI LIU
Chi Mei Medical Hospital
Investigators
Principal Investigator: WEI LUN LIU, MD Chi Mei Medical Center, Liou Ying
  More Information

No publications provided

Responsible Party: LUN WEI LIU, Chi Mei Medical Hospital
ClinicalTrials.gov Identifier: NCT01114009     History of Changes
Other Study ID Numbers: CLFHR9803
Study First Received: April 26, 2010
Last Updated: August 1, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chi Mei Medical Hospital:
recruitment maneuvers
ARDS
lung protective strategy
ARDS, Human

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Lung Injury
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014